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Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease

This study has been completed.
Sponsor:
Collaborator:
Biosyn
Information provided by (Responsible Party):
Dominik Bettinger, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT01355107
First received: May 6, 2011
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

The incidence of hepatocellular carcinoma (HCC) is rising worldwide.One important etiology is a chronic inflammation due to hepatitis c (hcv) infection. Over the steps of a chronic inflammation over the stadium of cirrhosis of the liver it is possible that neoplastic nodules appear in the liver which can rise up to a HCC. In the pathogenesis of HCC oxidative stress seems to play an important role and as selenium is a key micronutrient in this process its levels could differ between the different stages of disease in hcv- infected patients. The aim of this trial is to examine these differences.


Condition
Hepatitis C
Liver Cirrhosis
Carcinoma, Hepatocellular

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease - a Pilot Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • measurement of selenium levels in hcv- infected patients [ Time Frame: baseline ] [ Designated as safety issue: No ]
    measurement of selenium levels in whole blood samples


Secondary Outcome Measures:
  • selenium levels and inflammatory activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    determination if there is a correlation between selenium levels and inflammatory activity

  • selenium levels and stage of HCC (BCLC, UICC) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    determination if there is a correlation between selenium levels and the stage of HCC (BCLC, UICC)

  • selenium levels and MELD(Na)score [ Time Frame: baseline ] [ Designated as safety issue: No ]
    determination if there is a correlation between selenium levels and the MELD(Na)-score


Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 32
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
chronic hcv, no liver cirrhosis, no HCC
patients with chronic hepatitis c- infection: no cirrhosis of the liver (= Desmet IV), no HCC - suspected lesion in the liver
chronic hcv, liver cirrhosis, no HCC
patients with hcv- associated cirrhosis of the liver, but with no HCC - suspected lesions in the liver
hcv-infection, HCC
patients with hcv- associated HCC

Detailed Description:

The incidence of hepatocellular carcinoma (HCC) is rising worldwide. Almost all cases of HCC develop over clearly defined stages of chronic hepatic inflammation and cirrhosis of the liver which can be determined as an irreversible stage during this process. In the Western world excessive alcohol consumption and chronic infection with the hepatitis c virus (hcv) are frequent causes of chronic hepatocellular injury. As HCC is often diagnosed at advanced stages and therapeutic intervention possibilities are limited it becomes more and more necessary to search for prevention strategies to stop the development of HCC.

In the last years micronutrients such as selenium have reached the interests of oncologists. Several studies were able to show that there are often low selenium levels in patients with different tumors. Some epidemiologic studies showed that supplementation of selenium can decrease the incidence of some tumors.

Oxidative stress is meant to play an essential role in hepatocarcinogenesis and as selenium could decrease it, it may be possible that patients infected with the hepatitis c - virus show low selenium levels probably as a result of the chronic hepatic inflammation. Moreover there may be differences between the stages of disease namely chronic infection, cirrhosis of the liver and hepatocellular carcinoma. The aim of this trial is to determine these differences.

HCV- infected patients are enrolled in this trial. Three groups are formed: In Group 1 all HCV- infected patients with a chronic inflammation without cirrhosis of the liver and without HCC are summarized. in group 2 all HCV- infected patients with cirrhosis of the liver but without HCC are enrolled. In group 3 hcv- infected HCC- patients are summarized. In each group 10 patients should be enrolled, matched to age and other diseases. Blood samples are taken from these patients and selenium levels are measured.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Whole blood samples are taken from inpatients and outpatients of our primary care clinic

Criteria

Inclusion Criteria:

  • patients with chronic hepatitis c- infection: no cirrhosis of the liver (= Desmet IV), no HCC - suspected lesion in the liver
  • patients with hcv- associated cirrhosis of the liver: - cirrhosis of the liver confirmed by ultrasound, CT/MRI imaging or biopsy, all child - stages
  • patients with hcv- associated HCC: diagnosis of HCC according to the AASLD criteria, HCC has not been treated at the time of enrollment, all BCLC- /UICC- stages.
  • for all three groups: diagnosis of the chronic hcv- infection with virus rna and serologic parameters (anti-hcv) and abnormal liver function for more than 6 months, no antiviral treatment during the last 6 months

Exclusion Criteria:

  • application of dietary supplements
  • excessive alcohol consumption
  • all other etiologies leading to a liver injury
  • patients with an acute-phase- reaction, SIRS or patients in intensive care units
  • extrahepatic neoplasm
  • rheumatic disease apart from hcv- associated immunologic phenomena
  • diabetes mellitus I and II
  • immunological diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355107

Locations
Germany
University Medical Center Freiburg
Freiburg, Baden- Württemberg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Biosyn
Investigators
Principal Investigator: Hans Christian Spangenberg, Prof. Dr. University Medical Center Freiburg
  More Information

Publications:

Responsible Party: Dominik Bettinger, investigator, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01355107     History of Changes
Other Study ID Numbers: HCC1, DRKS00000813
Study First Received: May 6, 2011
Last Updated: December 13, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
selenium level measurement

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Selenium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants

ClinicalTrials.gov processed this record on May 16, 2013